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NCT04994717

Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia

Active, Not Recruiting
PHASE3Ages 40+InterventionalTreatment
Amgen
~303 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:BlinatumomabLow-intensity chemotherapy regimenSOC chemotherapy regimen

At a glance

Recruiting sites
0 of 192 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety run-in: Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)
Measured over Up to approximately 5 years
+2 more outcomes measured

Conditions

Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL)

NCT04994717

Where you'd take part

This study runs at 192 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Aalborg Universitetshospital

    Aalborg, Denmarkno site contact published

  • Aarhus Universitetshospital

    Aarhus N, Denmarkno site contact published

  • Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando

    Orlando, Floridano site contact published

  • Akita University Hospital

    Akita, Akita, Japanno site contact published

  • Ankara Bilkent Sehir Hastanesi

    Ankara, Turkey (Türkiye)no site contact published

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, Canadano site contact published

  • Attiko General University Hospital

    Athens, Greeceno site contact published

  • Austin Health, Austin Hospital

    Heidelberg, Victoria, Australiano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • MD · STUDY_DIRECTOR · Amgen

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

history of grades 3 and 4 pancreatitis
diabetes mellitus with end-organ damage
severe liver disease such as cirrhosis stage 2 with portal hypertension or history of esophageal variceal bleeding and aspartate transaminase (AST)/alanine aminotransferase (ALT) \> 10 x upper limit of normal (ULN) (liver cirrhosis must be confirmed by biopsy)
body mass index (BMI) ≥ 40 combined with relevant comorbidities such as metabolic syndrome
Any further combination of documented severe comorbidities that the investigator judges to be incompatible with administering an intensive pediatric based, adult adapted standard chemotherapy regimen but still compatible with the suggested protocol for older participants in both the experimental and the SOC arm. The participant history will be reviewed by the medical monitor during screening to determine enrollment acceptability based on a standard list with types of comorbidities allowed.
Participants with newly diagnosed Philadelphia (Ph)-negative B-cell precursor acute lymphoblastic leukemia (ALL)
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, higher ECOG score allowed if due to underlying leukemia
All participants must have adequate organ function as defined below:
renal: estimated glomerular filtration rate based on MDRD calculation ≥ 50 mL/min/1.73 m\^2
liver function: total bilirubin ≤ 2x upper limit of normal (ULN; unless Gilbert's Disease or if liver involvement with leukemia); exception for participants 40 to \< 55 years of age if they have a comorbidity listed above: severe liver disease such as cirrhosis stage 2 with portal hypertension or history of esophageal variceal bleeding and AST/ALT \> 10 x ULN (liver cirrhosis must be confirmed by biopsy)
cardiac: left ventricular ejection fraction (LVEF) ≥ 50% and no clinically significant, uncontrolled, or active cardiovascular disease (eg, myocardial infarction or stroke within 3 months). Consult with medical monitor as needed.

Exclusion

Active central nervous system (CNS) leukemia (i.e., CNS 3 leukemia, confirmed by lumbar puncture) not resolved with IT chemotherapy during screening.
History of other malignancy within the past 3 years, with the following exceptions:
Malignancy treated with curative intent and with no known active disease present for ≥ 3 years before enrollment and felt to be at low risk for recurrence by the treating physician Note: History of other malignancy (eg, multiple myeloma) treated with immunomodulatory drugs (eg, lenalidomide, thalidomide) in the past 3 years is an exclusion.
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
Adequately treated cervical carcinoma in situ without evidence of disease
Adequately treated breast ductal carcinoma in situ without evidence of disease
Prostatic intraepithelial neoplasia without evidence of prostate cancer
Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ
Clinically relevant CNS pathology or event such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychiatric conditions that preclude the use of high dose of corticosteroids
Current autoimmune disease or history of autoimmune disease with potential CNS involvement
Known infection with human immunodeficiency virus (HIV)
Known infection with chronic or active infection with hepatitis B (eg, hepatitis b surface \[HBs\] antigen reactive or quantifiable hepatitis b virus \[HBV\] viral load) or hepatitis C virus (HCV) (eg, HCV RNA \[qualitative\] is detected).
positive for hepatitis B surface antigen (HepBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B)
negative HepBsAg and positive for hepatitis B core antibody: negative HBV DNA by PCR result is necessary to enroll.
positive Hepatitis C virus antibody (HepCAb): negative hepatitis C virus RNA by PCR result is necessary to enroll.
Participant with symptoms and/or clinical signs and/or radiographic and/or sonographic signs that indicate an acute or uncontrolled chronic infection.
Cancer chemotherapy for this newly diagnosed B cell ALL before the start of protocol-required therapy with the exception of IT chemotherapy or optional pre-phase (debulking) chemotherapy. Radiation to a spot lesion such as chloroma or lytic lesion of bone or vertebrae for pain or vertebral stabilization is allowed.

What this trial measures

  • Safety run-in: Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)Up to approximately 5 years

    Number and percentage of participants who experience one or more TEAE, serious TEAE, treatment-related adverse events, and adverse events of interest.

  • Phase 3: Event-free Survival (EFS)Up to approximately 5 years

    Time from randomization (enrollment) until treatment failure, relapse or death from any cause, whichever is earlier. Treatment failure is defined as not achieving a hematological complete CR with MRD response \<10-4 by the end of the initial disease assessment period. Relapse is defined as hematologic relapse, extramedullary relapse, and/or molecular relapse (MRD positivity \>= 10\^-3), whichever occurs earlier, in participants with prior achievement of hematologic CR with MRD response \<10\^-4. Participants without an event will be censored at their last evaluable disease assessment date.

  • Phase 3: Overall Survival (OS)Up to approximately 5 years

    OS is defined as time from randomization (enrollment) until death due to any cause.